NEW YORK, Jan. 10, 2020 (GLOBE NEWSWIRE) -- Seelos Therapeutics, Inc. (SEEL), a clinical-stage biopharmaceutical company focused on the development of therapies for central nervous system disorders and rare diseases, today announced interim data from its Phase I study of Intranasal Racemic Ketamine (SLS-002).
Interim data from study SLS-002-101 demonstrated that 60mg of SLS-002, when administered as a monotherapy and in combination with an oral antidepressant, was generally safe and well-tolerated. All adverse events (AEs), except for one, were deemed mild or moderate. All AEs were transient in nature, consistent with the known profile of the drugs, and all resolved without medical intervention. The interim results from the study have not revealed any new or unique safety signals, there were no serious adverse events (SAEs), and only one of 42 subjects discontinued the trial prematurely (withdrawal on the last day of dosing due to an AE but completed the evaluation).
“This study is highly encouraging in regard to the side effect profile of SLS-002,” said Raj Mehra, Ph.D., Chairman and CEO of Seelos. “We look forward to releasing data throughout the quarter as additional study cohorts are completed and evaluated.”
Study SLS-002-101 is a single-center, open-label study which enrolled 42 healthy volunteers, studied over 14 days, randomized into two treatment arms and dosed with a combination of 60mg of SLS-002 and either, venlafaxine ER or sertraline. The primary objective of this study was to evaluate the pharmacokinetic (PK) profile, drug-drug interaction (DDI), and safety measures of SLS-002.
Seelos recently received Fast Track designation for SLS-002 for the treatment of Acute Suicidal Ideation and Behavior (ASIB) in patients with Major Depressive Disorder (MDD).
Additional data from the ongoing Phase I studies of SLS-002 to evaluate the pharmacokinetics (PK), pharmacodynamics (PD), and safety of multiple, repeated, single doses of SLS-002 as well as IV ketamine is expected throughout the first quarter of 2020.
Statements made in this press release, which are not historical in nature, constitute forward-looking statements for purposes of the safe harbor provided by the Private Securities Litigation Reform Act of 1995. These statements include, among others, those regarding the interim results of Study SLS-002-101, expectations regarding the timing for receiving additional data from the Phase I studies of SLS-002 to evaluate the PK. PD and safety of multiple, repeated, single doses of SLS-002 as well as IV ketamine, expectations regarding the side effect profile of SLS-002 and Seelos’ plans to release additional data from such studies and the expected timing thereof. These statements are based on Seelos’ current expectations and beliefs and are subject to a number of factors and uncertainties that could cause actual results to differ materially from those described in the forward-looking statements. Risks associated with Seelos’ business include, but are not limited to, the risk of not successfully executing its clinical studies and not gaining marketing approvals for its product candidates, the risks associated with the implementation of a new business strategy, the risks related to raising capital to fund its development plans and ongoing operations, as well as other factors expressed in Seelos’ periodic filings with the U.S. Securities and Exchange Commission, including its Annual Report on Form 10-K and Quarterly Reports on Form 10-Q. Although we believe that the expectations reflected in our forward-looking statements are reasonable, we do not know whether our expectations will prove correct. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof, even if subsequently made available by us on our website or otherwise. We do not undertake any obligation to update, amend or clarify these forward-looking statements, whether as a result of new information, future events or otherwise, except as may be required under applicable securities laws.
Head of Corporate Communications
Seelos Therapeutics, Inc. (SEEL)
300 Park Ave., 12th Fl
New York, NY 10022